(115 days)
The Bard® No-rinse Hemoconcentrator is intended for the relief or mitigation of overhydration in patients undergoing cardiopulmonary procedures and to increase the concentration of cells and proteins in the blood.
The Bard No-rinse Hemoconcentrator and accessory kit for hemoconcentration serve the needs of cardiopulmonary procedures. Connected to the external cardiopulmonary blood circuit, the hemoconcentrator generates ultrafiltrate with electrolyte and solute compositions similar to that of plasma water. The Bard' No-rinse Hemoconcentrators are made of glycerin-free polysulphone membranes. The no-rinse feature provides convenience of inserting the device into the external cardiopulmonary blood circuit without the need to rinse the device.
The provided text describes a 510(k) summary for the Bard® No-rinse Hemoconcentrator and Accessory Kit, HC40TS. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than conducting a full-scale clinical study with acceptance criteria and statistical proof of meeting those criteria in the way an AI/ML device would.
Therefore, many of the requested items (sample size, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth establishment) are not applicable to this type of device submission as they were not part of the required evaluation.
However, I can extract the information relevant to how the device's performance was evaluated for substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, "acceptance criteria" are implied by the performance of the predicate devices. The new device must perform in a "substantially equivalent" manner. There aren't explicit numerical acceptance criteria stated, but rather a comparison to established devices.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate: Fresenius Hemoflow F40) | Reported Device Performance (Bard HC40TS) |
|---|---|---|
| Cell damage | Similar to predicate device | Performs in a manner substantially equivalent to predicate devices |
| Protein analysis | Similar to predicate device | Performs in a manner substantially equivalent to predicate devices |
| Sieving coefficient | Similar to predicate device | Performs in a manner substantially equivalent to predicate devices |
| Dynamic prime volume | Similar to predicate device | Performs in a manner substantially equivalent to predicate devices |
| Ultrafiltration rate | Similar to predicate device | Performs in a manner substantially equivalent to predicate devices |
| Pressure drop | Similar to predicate device | Performs in a manner substantially equivalent to predicate devices |
2. Sample Sizes used for the test set and data provenance
- Test Set Sample Size: Not explicitly stated as a "test set" in the context of an AI/ML device. Performance testing was conducted to show substantial equivalence to predicate devices. The number of units or tests performed for each characteristic (cell damage, protein analysis, etc.) is not specified.
- Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. It describes laboratory/bench testing ("performance testing") rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical device (hemoconcentrator), not an AI/ML diagnostic or prognostic system requiring expert-established ground truth on a test set. Evaluation relies on physical and functional performance testing.
4. Adjudication method for the test set
Not applicable. As above, this is not an AI/ML system requiring expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a physical medical device, not an AI system. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an AI algorithm. Its performance is inherent to its physical characteristics and functionality.
7. The type of ground truth used
For the performance characteristics (cell damage, protein analysis, etc.), the "ground truth" is established through standard laboratory and engineering tests, comparing the new device's performance to the known performance of predicate devices according to established industry and regulatory standards for such devices. The "truth" is the measured physical and functional properties of the device.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML system that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device.
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”